Proventil HFA albuterol inhalers recalled for manufacturing temperature deviation
Proventil HFA inhalers are being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during manufacturing, a deviation from FDA Good Manufacturing Practice standards.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a manufacturing deviation (temperature abuse) but with no reported illnesses, injuries, or adverse events. The hazard is precautionary rather than based on confirmed harm, consistent with typical Class II recall patterns.
Plain-English summary
Proventil HFA (Albuterol Sulfate Inhalation Aerosol), a prescription-only bronchodilator inhaler manufactured by Merck Company, is being recalled nationwide. The recall covers 22 inhalers distributed by McKesson Medical-Surgical Inc. The reason for the recall is temperature abuse, which constitutes a deviation from FDA Good Manufacturing Practice (cGMP) standards.
McKesson Medical-Surgical states that it is unable to identify the specific lot numbers received by individual customers. The company is notifying customers directly with the dates when affected product was distributed and shipped.
Patients who have received this product should contact their pharmacist or healthcare provider. They should not use the recalled inhalers and should dispose of them according to their pharmacist's instructions or follow their local drug disposal guidelines.
The recalled product
- Product
- Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Respiratory / Inhalant
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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